Symbicort now registered for mild asthma

New indication means budesonide/formoterol can be prescribed as needed (PRN) for patients with mild asthma, without daily maintenance treatment

Symbicort Turbuhaler 200/6 and Symbicort Rapihaler 100/3 can now be prescribed to Australian adult and adolescent asthma patients (12 years and over) of any asthma severity, following registration by the TGA to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations.

While Symbicort (budesonide/formoterol), taken as needed, is already approved in combination with Symbicort maintenance treatment in moderate-to-severe asthma, the new indication enables healthcare professionals to prescribe Symbicort anti-inflammatory reliever as needed (PRN) for patients with mild asthma, without daily maintenance treatment.

Changes to the product information and ARTG indication are based on the results of two trials, explains consultant clinical pharmacist and asthma educator Debbie Rigby.

“Overall the results say there is a reduction in the number of severe exacerbations,” she told AJP.

“Typically people with mild intermittent asthma will just rely on SABAs such as Ventolin, but underpinning all this is that asthma is a chronic inflammatory disease.

“The SABA is doing nothing for the underlying inflammation. Yes, it’s helping with the symptoms due to bronchoconstriction, but it’s doing nothing for the inflammation,” said Ms Rigby.

“The idea of using the inhaled corticosteroids/formoterol PRN is that the formoterol is quick acting, it’s just as quick as salbutamol but is long acting – lasting 12 hours. They’re getting relief from their symptoms but also getting a dose of ICS that is impacting positively on the inflammation process that’s going on.

“So the trial was showing less severe exacerbations because they’re getting inhaled corticosteroids as well as their bronchodilator.”

Ms Rigby said pharmacists need to have a conversation with patients about the new indication.

“At the moment Symbicort is not on the PBS for this specific indication (PRN for mild asthma), so there’s a cost implication and I think that’s one of the barriers to its implementation at the moment,” she said.

“We need to have a conversation with patients. We should know from our records how many over-the-counter SABAs a patient is taking. Over-the-counter Ventolin might cost $8, but some people are going through one inhaler a week or more. Meanwhile the cost of a Symbicort on a private script will be roughly $35-$40.

“I think we’ve just got to help patients to understand the benefits of taking Symbicort PRN, reinforcing if they do need to take it regularly the benefits of that.

“For people with mild intermittent asthma, these trials clearly show it is more effective than SABA across a whole range of clinical parameters. They might save money in the long run if they’re using lots of SABA.

The National Asthma Council Australia has recently updated the Australian Asthma Handbook, detailing factors associated with increased risk of life-threatening asthma, including high SABA use.

“There is increasing research around the dangers of over-using reliever-only medication and not adhering to treatment recommendations,” said Professor Christine Jenkins, Head of the Respiratory Group at The George Institute for Global Health.

“It is important that healthcare professionals educate patients on the risks associated with misuse of their short-acting reliever medication.

“This new indication for a fast onset long acting bronchodilator combined with an inhaled corticosteroid provides an alternative treatment choice and way of treating mild asthma.”

Professor Jenkins added: “Patients and healthcare professionals must be aware this is specific to Symbicort and does not apply to all asthma medications.”

In Australia, 2.7 million people live with asthma, with about one million of these living with mild asthma.

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